TPLC - Total Product Life Cycle

• Device: drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
• Definition: Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.
• Product Code: NVN
• Device Class: 3

Premarket Approvals (PMA)
2007	2008	2009	2010	2011	2012	2013
0	1	10	10	11	19	2

Device Problems
Failure to capture	2074
Dislodged or dislocated	1975
No code available	1707
High impedance	1508
Device sensing issue	1239
Fracture	1071
Oversensing	872
No Information	566
Material integrity issue	525
No Known Device Problem	485
Low impedance	466
High sensing threshold	401
Failure to pace or properly pace	344
Capturing issue	307
Difficult to position	276
Impedance issue	252
Failure to sense	208
Failure to deploy	195
Undersensing	190
Mechanical issue	143
Connection issue	138
High capture threshold	122
Pocket stimulation	108
Retraction problem	103
Device operates differently than expected	101
Difficult to remove	91
Intermittent capture	73
Electrical issue	47
Break	38
Human-Device Interface Issue	38
Patient-device incompatibility	34
Defective item	33
Device damaged prior to use	33
Difficult to deploy	32
Low sensing threshold	29
Noise	29
Electrode(s), failure of	28
Degraded	27
Dislodged	25
Sensing intermittently	25
Disinfection or Sterilization Issue at User Location	24
Migration of device or device component	22
Loss of threshold	21
Artifact	20
Product quality issue	19
Device remains activated	19
Failure to advance	17
Use of Device Issue	17
Inappropriate shock	16
Other (for use when an appropriate device code cannot be identified)	15
Cut in material	14
Difficult to insert	14
Deployment issue	14
Bent	13
Unknown (for use when the device problem is not known)	13
Steering wire problem	13
Device Contamination with biological material	12
Communication or transmission issue	10
Explanted	10
Loose or intermittent connection	10
Mislabeled	9
Component(s), broken	9
Out-of-box failure	8
Incomplete or missing packaging	8
Material deformation	8
Pacing inadequately	8
Device contamination with blood or blood product	7
No pacing	7
Installation-related problem	7
Size incorrect for patient	7
Difficult to advance	7
Device displays error message	6
Invalid sensing	6
Decreased sensitivity	6
Buckled material	5
Pacing intermittently	5
Incorrect measurement	5
Hole in material	5
Misconnection	5
Insulation, hole(s) in	5
Low readings	4
Device abrasion from instrument or another object	4
Detachment of device or device component	4
Implant, repositioning of	4
Connection error	4
Device remains implanted	4
Positioning Issue	4
Device or device component damaged by another device	4
Unstable capture threshold	4
Material Distortion	4
Foreign material present in device	3
Device operational issue	3
Material discolored	3
Crack	3
Normal	3
Insulation, detached	3
Detachment of device component	3
Lead(s), fracture of	3
Kinked	3
Device or device fragments location unknown	2
Total Device Problems	16473